MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. PASSIVE PLANAR BLUNT PROBE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	960-556
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a navigation system being used in an unknown procedure.It was reported that during a cranial case, they were having issues with the camera not seeing the registration probe.The site was able to complete the registration but they had intermittent tracking issues with the probe.It was noted that the probable cause of the issue was a damaged instrument.Delay information was not provided.It was unknown if there was an impact to the patient.It was reported that after further troubleshooting with the passive planar probe instrument, after placing new spheres and covering each sphere, when covering the middle prong sphere, the system was unable to track the instrument.
Additional Manufacturer Narrative
H3, h6: no products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the procedure was a cranial resection.The issue occurred intra-operatively and caused an under 5 minute surgical delay.There was no reported impact on patient outcome.
Additional Manufacturer Narrative
H2) additional information added to section a.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PASSIVE PLANAR BLUNT PROBE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23490494
• Report Number: 1723170-2025-03665
• Device Sequence Number: 8551969
• Product Code: HAW
• UDI-Device Identifier: 00673978090122
• UDI-Public: (01)00673978090122(11)141121(10)141121
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K972398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 960-556
• Device Catalogue Number: 960-556
• Device Lot Number: 141121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 11/17/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 11/17/2025; 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 118 KG